Multicenter RCT of SSRF in Non Flail Patients

Rib fracture are the most common serious injury following blunt trauma, and occur in
approximately 10% of trauma patients [1]. Despite improvements in the care of rib fracture
patients, outcomes remain poor and have not changed substantially over the last 15 years [2].
Poor outcomes resulting from serious rib fractures include both acute complications (e.g.,
pneumonia, prolonged mechanical ventilation, and death) and chronic disability (e.g., pain,
dyspnea, and loss of productivity).

Over the last 10 years, surgical stabilization of rib fractures (SSRF) has emerged as a
promising technology for the management of patients with severe chest wall injuries [3].
Conceptually, SSRF applies the fundamental orthopedic principles of reduction and fixation to
rib fractures, restoring chest wall stability and minimizing pain with respiration,
splinting, and secretion accumulation. The advent of muscle-sparring [4] and even
minimally-invasive surgical techniques [5], as well as a relatively low complication rate
[6], has improved the appeal of this operation.

To date, three randomized clinical trials (RCTs) [7-9] and three meta-analyses of these and
other trials [10-12] have limited their scope to patients with flail chest, a specific
clinical diagnosis characterized by paradoxical motion of a portion of the chest wall due to
fractures of two or more ribs in at least two places. Flail chest represents the most severe
form of chest wall injury, with an associated, very high morbidity and mortality. Each of the
aforementioned RCTs, as well as multiple prospective, non-randomized investigations [13, 14],
have found a benefit to SSRF as compared to best medical management in this patient
population. Accordingly, expert consensus statements have recommended this operation in this
subset of patients [3, 15].

Based upon the favorable reported efficacy of SSRF in patients with flail chest, many
surgeons have broadened indications to patients with severe, non-flail rib fracture patterns,
most commonly ≥ 3 severely displaced fractures. Although these injuries differ anatomically
from flail chest, many of the same pathophysiologic principles are at work: namely, painful
motion at the fracture sites cause respiratory compromise, bony bridging [16], and risk of
subsequent non-union, chronic pain, and restrictive lung disease. However, it is not clear if
stabilization of these fractures confers the same benefits as in the case of flail chest.
This lack of efficacy data has been recognized in recent guidelines, which were unable to
recommend SSRF for non-flail fracture patterns pending further data. Furthermore, long term
quality of life data for both flail and non-flail fracture patterns managed with SSRF are not
available.

The use of SSRF is increasing exponentially. Somewhat alarmingly, nearly one half of the
procedures were performed in patients without flail chest [17]. A combination of the
favorable results observed for SSRD in flail chest, the increasing prevalence of SSRF for non
flail-chest, and the lack of quality evidence to support this operation in this patient
population, lead to the design of the current RCT. The objective of this trial is to
investigate the efficacy of SSRF, as compared to non-operative management, for hospitalized
patients with specific, non-flail, severe rib fractures, and within expert, high volume
centers that participate in the Chest Wall Injury Society. The investigators hypothesize that
SSRF, as compared to standardized medical management, improves pain control, pulmonary
function, risk of complications, and quality of life among patients with severe, non-flail
chest fracture patterns.

Inclusion Criteria:

1. Hospitalization with ≥ 3 severely displaced (≥ 50% of rib width) acute rib fractures.

2. Two or more of the following pulmonary physiologic derangements (at the time of
consideration for enrollment and after best medical therapy).

1. Respiratory rate > 20 breaths per minute

2. Incentive spirometry < 50% predicted (appendix D)

3. Numeric pain score > 5

4. Poor cough (as documented by respiratory therapist)

3. Surgery anticipated < 72 hours from injury

Exclusion Criteria:

1. Age < 18 years or ≥ 80 years

2. Flail chest: either radiographic or clinical. Radiographic flail chest is defined on
CT chest as ≥ 2 ribs each fractured in ≥ 2 places. Clinical flail is defined as
visualization of a segment of chest wall with paradoxical motion on physical exam.

3. Moderate or severe traumatic brain injury (GCS at the time of consideration for
enrollment < 12)

4. Intubation

5. Severe pulmonary contusion, defined as Blunt Pulmonary Contusion 18 (BPC18) score > 12
[19].

6. Prior or expected emergency exploratory laparotomy during this admission.

7. Prior or expected emergency thoracotomy during this admission.

8. Prior or expected emergency craniotomy during this admission.

9. Spinal cord injury

10. Pelvic fracture that has required, or is expected to require, operative intervention
during this admission.

11. The patient was unable to accomplish activities of daily living independently prior to
injury (e.g., dressing, bathing, prepearing meals).

12. Pregnancy.

13. Incarceration.